9 results
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22ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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TR BAND Radial Compression Device
FDA 510(k)
FDA Class 2
·Cardiovascular
QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00
FDA 510(k)
FDA Class 2
·Radiology
UNBALLOON NON-OCCLUSIVE MODELING CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
HD EPSCP,4.0,0,175,CW_STORZ
FDA Adverse Event
Malfunction
·MEDOS INTERNATIONAL SARL·Product code HRX·April 10, 2024
RUNTHROUGH NS
FDA Adverse Event
Injury
·TERUMO CORPORATION, ASHITAKA·Product code DQX·October 30, 2014
ANIMAS INSULIN CARTRIDGE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·August 16, 2011
ENDOTAK RELIANCE
FDA Adverse Event
Injury
·CPI - DEL CARIBE·Product code NVY·July 9, 2013
18L6 HD transducer on the ACUSON S Family ultrasound systems with software versions VD10A or VD10C; Model numbers: 18L6 HD transducer 10041227 & 10789400 S1000 10441701 S2000 10041461 S2000 (Refurb) - 10440017 S3000 10441730 Radiology: The ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·May 3, 2017
Alcon Custom Pak
FDA Enforcement
Class II
·Ongoing·Alcon Research, LTD.·August 23, 2023